510(k) Report

FDA applicant

Nanostring Technologies, Inc.

Seattle, WA2 decisions2013–20140 recalls

FDA records 2 decisions for Nanostring Technologies, Inc. (Seattle, WA) from 2013 to 2014: 2 510(k) clearances. All are in product code NYI (Classifier, Prognostic, Recurrence Risk…). Its devices cite 3 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Nanostring Technologies”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, immunology panel, where it files most

How often FDA has decided Nanostring Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2013: 12014: 1
2013high 1 (2013) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Nanostring Technologies, Inc. by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Nanostring Technologies, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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